The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Dicompacs, Model 5.
| Device ID | K070618 |
| 510k Number | K070618 |
| Device Name: | DICOMPACS, MODEL 5 |
| Classification | System, Image Processing, Radiological |
| Applicant | OEHM UND REHBEIN GMBH WALDEMSRSTR. 20G/H Rockstock, DE 18057 |
| Contact | Franziska Gunther |
| Correspondent | Franziska Gunther OEHM UND REHBEIN GMBH WALDEMSRSTR. 20G/H Rockstock, DE 18057 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-04-25 |
| Summary: | summary |